近期，FDA颁布了在新冠肺炎疫情期间口罩禁忌授权，并发布了相关指南COVID19-Face-Masks-Guidance，今天针对KN95,详细的解读相关内容：
KN95绿色通道产品代码的使用：
MSH是针对KN95系列产品所使用的代码
如何获取EUA的资质：
需要向FDA官方提交以下资料
- General information such as your contact information, name and place of business,email address, and contact information for a U.S. agent (if any) in addition to generalinformation about the device such as the proprietary or brand name, model number,and marketing authorization in your country (or region).
注解：提供公司的基本相关产品信息
- copy of the product labeling.
注解：产品说明书复印件
- Whether the device currently has marketing authorization in another regulatory jurisdiction (including certification number, if available).
注解：相关管辖地区，或相关资质的认可证明，经营许可等
- Whether the device is manufactured in compliance with 21 CFR Part 820 or ISO13485: Medical Devices – Quality Management Systems – Requirements forRegulatory Purposes or an equivalent quality system and the manufacturer or importer has documentation of such.
注解：QSR820体系或ISO13485体系相关证明
- Description of testing conducted on the device, including any standards met, such as
注解：产品描述，适用相关标准清单
- liquid barrier protection, flammability, biocompatibility, and filtration performance, asappropriate. For surgical N95 respirators, FDA recommends including fluid resistance testing (liquid barrier performance).
注解：相关的性能测试
特别注意：
- FDA只是减免了NIOSH认证的方式，不过相关测试必不可少
- 测试标准可以按照欧盟标准，国标，日本标准，澳洲标准等，不局限于美标
- 提交的相关资料尽可能更加全面，更加权威
- EUA通过后，需要在包装添加FDA紧急授权产品
愿疫情早日结束！
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